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Certificate no.
PL-26-00315
Verification key
PNK8UE58
Scan or enter both at prymalab.net/testing/verify
Certificate of Analysis · Lot release
Tesamorelin 10 mg Pen
Lot PL-2610-203 · Solution · Label claim 10 mg/mL
Tested in-house by PrymaLab
In-house analytical result, not an independent third-party test
Lot / batch number
PL-2610-203
Date made
2026-10-07
Date of analysis
2026-10-09
Date issued
2026-10-23
Retest / expiry
2028-10-07
Units in lot / sampled
284 / 2
Storage
—
Certificate type
Lot COA, 2 pages
Compound
Tesamorelin
Tesamorelin (trans-3-hexenoyl-GHRH(1-44)-NH2)
CAS number
218949-48-5
Molecular formula
C221H366N72O67S
Theoretical mass (avg.)
5,135.86 Da
Sequence
GHRH(1-44) analog
Purity · RP-HPLC, area %
99.30%
Specification ≥ 99.0% • main peak at 11.70 min
Identity · Observed Mass
5,135.68 Da
Theoretical 5,135.86 Da • −0.18 Da (35 ppm)
Overall conclusion
PASS
Meets every specification for the tests performed
Test
Method
Specification
Result
Conclusion
Identity (mass)
LC-MS, ESI positive
Theoretical ± 1.0 Da
5,135.68 Da
PASS
Purity
RP-HPLC, UV 214 nm, area%
≥ 99.0%
99.30%
PASS
Largest impurity
RP-HPLC, area%
≤ 1.0%
0.35% (RT 10.40)
PASS
Assay (label claim)
Assay vs label claim
9.5–10.5 mg/mL
9.76 mg/mL
PASS
Bacterial endotoxin
LAL, kinetic
≤ 5.0 EU/mg
0.108 EU/mg
PASS
Sterility
USP <71>, 14-day
No growth
No growth
PASS
1HPLC chromatogram
Data file: PL-2610-203-HPLC.raw · Column C18, 150 × 4.6 mm · UV 214 nm
Peak plot drawn from the integrated peak table (area %, log scale); it is not the instrument trace, which is retained in PL-2610-203-HPLC.raw. † Nominal reference retention time for the assigned impurity; the main-peak RT is observed in this lot.
PrymaLab
Certificate of Analysis · continued
Tesamorelin 10 mg Pen · Lot PL-2610-203 · Certificate PL-26-00315
Lot PL-2610-203
Method, peak table and approval
2HPLC method · PL-2610-203-HPLC.raw
Instrument
Waters Alliance e2695
Data System
Empower 3
Detector
UV absorbance
Detection Wavelength
214 nm
Column
C18, 150 × 4.6 mm, 3.5 µm
Mobile Phase A
0.1% TFA in water
Mobile Phase B
0.1% TFA in MeCN
Gradient
5–95% B over 25 min (linear)
Flow Rate
1.0 mL/min
Column Temperature
40 °C
Injection Volume
10 µL
3Gradient program
Time (min)
% A
% B
0.0
95
5
25.0
5
95
4Peak table
Peak
RT (min)
Area
Area %
1
10.40 †
—
0.35
2
11.20 †
—
0.13
3
11.70
—
99.30
4
13.00 †
—
0.22
Total
—
100.00
Peaks: 1 deamidation product; 2 isoaspartate (isoasp) variant; 3 main peak (Tesamorelin); 4 tryptophan oxidation product · Area % from the integrated peak table (absolute areas are not part of the lot-release export) · † nominal reference RT for the assigned impurity · Purity = main peak area ÷ total integrated area × 100, to two decimals; main peak shaded.
5Identity by mass spectrometry
Instrument
Waters SQD
Ionization / Mode
ESI, positive
Reference m/z (charge)
1284.97 (4+) · 1028.18 (5+)
Deconvoluted Mass
5,135.68 Da
Theoretical Mass
5,135.86 Da
Difference
−0.18 Da (35 ppm)
Data File
PL-2610-203-MS.d
Acceptance
Within ± 1.0 Da
6Additional tests
Test
Performed by
Date
Report / file
Assay vs label claim
PrymaLab Analytical
2026-10-09
—
Endotoxin (LAL, kinetic)
PrymaLab Analytical
2026-10-09
—
Sterility (USP <71>, day-14 read-out)
PrymaLab Analytical
2026-10-23
—
A test with no row here was not performed on this lot. Outside-laboratory reports, when used, are attached and named below.
7Review and approval
D. Reynolds Analyst · performed the testing Date: 2026-10-23
S. Calloway Reviewer · checked against raw data Date: 2026-10-23
M. Phelps Lab Director · approved for release Date: 2026-10-23
